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Ethics Matters

Too Old to Benefit? Why are so Few Seniors in Cancer Research?

January 10, 2000
Web posted at: 5:04 p.m. EST (2204 GMT)



by Jeffrey P. Kahn, Ph.D., M.P.H.
Director, Center for Bioethics
University of Minnesota

A study recently published in the New England Journal of Medicine reported that patients over 65 years old are substantially under-represented in research trials for new cancer treatments. Just 25 percent of those in cancer trials were over 65, whereas it is estimated that 63 percent of those in the U.S. with cancer are over 65. Such under-representation in research could have serious implications for the quality of cancer care for the elderly, and raises ethical issues about who should benefit from clinical research and how both the benefits and burdens of research ought to be shared.

Center
for Bioethics

What's your opinion?
A history of exclusion

Some groups were intentionally excluded in the past from research participation, either by explicit policies intended to protect their health, or through less direct means such as limited access to health care which is often the front door to research participation. For example, from the late 1970s until the mid-1990s federal policy limited women's and children's participation to low risk research -- in the interest of protecting women's childbearing capacity, or to assure that children were not exploited given their limited ability to make decisions. These were real concerns and the policies reflected the careful thinking of the time. Less reflective, and certainly not dictated by policy, patients without adequate insurance have long been rejected from participating in clinical research because its associated medical costs will not be covered.

From protection to access

The effects of the routine exclusion of specific groups from research is that much less is known about health, disease, and appropriate treatment in those groups. For example, data that showed an aspirin a day reduced the risk of heart attack was the result of a large study of exclusively men. And since women also suffer from heart attacks but are not merely smaller versions of men, the aspirin study results could not be applied to women's health. This fact was not lost on advocacy groups, particularly groups lobbying for research into treatments for breast cancer, which spearheaded efforts to change research rules. They won change in policies that turned the presumption of protection on its head. Instead of presuming that women should automatically be "protected" (to death?) from research, NIH policy was changed in the 1990s to require that women represent a proportional part of every research study unless they are ineligible for other reasons (say in a study of prostate cancer!). This change has resulted in great benefit to women generally, through new medical information, as well as in benefits to individual women who may gain direct medical benefits from being in the research.

Targeting the elderly?

Unlike past general policies of exclusion of women or children from research that was aimed at protection, there have been no explicit policies excluding the elderly from research, and in fact we don't know the reasons why they are so under-represented. It may be some combination of exclusion and a choice not to participate. Such a choice would be reasonable enough, give that while research participants may benefit from research or the medical care that goes along with it, research benefits are usually not for the individuals themselves. The benefits of research will mostly fall to future patients. But like anybody else, elderly patients deserve to make their own decisions about the risks they'll take, the gains they'll enjoy as well, and the benefits they'll contribute to the next generation of the elderly.

As Baby Boomers age and create an even larger population of seniors, the demand for medical care directed to them will dramatically increase. They are neither too old to benefit from research nor too feeble to decide when to participate in it. The financial support that launched the biomedical research revolution was won on the financial backs of the generation that will soon become the largest population of seniors in our country's history. It would be ironic if they were denied the benefits of the research they made possible.



A study recently published in the New England Journal of Medicine reported that patients over 65 years old are substantially under-represented in research trials for new cancer treatments. Just 25 percent of those in cancer trials were over 65, whereas it is estimated that 63 percent of those in the U.S. with cancer are over 65. Is it fair that the elderly are so under-represented in cancer research? Should policy be changed to require greater opportunities for seniors to participate in research and realize its benefits? Should more seniors be encouraged to enroll in research to share the burden of the risks in such research?

Post your opinion here.



Visit the
"Ethics Matters" Archive
where you'll find other columns from Jeffrey Kahn
on a wide range of bioethics topics.


"Ethics Matters" is a biweekly feature from the
Center for Bioethics and CNN Interactive.


RELATED STORIES:
Elderly underrepresented in cancer studies
December 29, 1999

RELATED SITES:
New England Journal of Medicine
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